Open-label Treatment Extension Study for Patients Who Com... | NCT00230490

Studies
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

NCT00230490

Sponsor

Bausch Health Americas, Inc.

Status

Terminated

Last Update Posted

Nov 29, 2019Actual

Enrollment

150

Phase

Phase 2

Conditions

Hepatitis B, Chronic

Interventions

pradefovir mesylate
adefovir dipivoxyl

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Adverse findings from nonclinical carcinogenicity studies.

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Sep 28, 2005

First Submission Date that Met QC Criteria

Sep 28, 2005

First Posted Date

Sep 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2019

Last Update Posted Date

Nov 29, 2019Actual

Description Module

Brief Summary

Compare the long-term safety of pradefovir to adefovir dipivoxyl

Detailed Description

Compare the long-term safety of pradefovir to adefovir dipivoxyl
Monitor development of resistance
Evaluate virologic and biochemical response

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- Safety: Clinical examinations of laboratory tests
- Efficacy: Change in viral load over time

Secondary Outcomes

Measure	Description	Time Frame
- Efficacy: Proportion of patients with undetectable viral load

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who completed 48 weeks of treatment in study RNA200103-201

Exclusion Criteria:

Patients who were determined to be treatment failures in study RNA200103-201
Patients who experienced a serious adverse event judged to be related to study drug in study RNA200103-201
Patients with a serum creatinine greater than 2.0 mg/dl on two consecutive determinations in study RNA200103-201

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ralph T. Doyle	Bausch Health Americas, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C497721	pradefovir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
pradefovir mesylate	Drug
adefovir dipivoxyl	Drug